FDA.reportPublic FDA data

OpsisDx

Primary DI
B550ENT0100
Brand
OpsisDx
Company
ENTOPSIS, LLC
Model
Quality Control Tray
Catalog number
ENT010
Device description
Metal tray used for quality control of OpsisDx heater
Published
2021-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B550ENT0100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078294784
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5502280250PCRopsisActivator2280252022-06-10
B550783360010PCRopsisReagent RVD with RVD Enhancer783360012024-04-11
B55026682504PCRopsisConcentrator26682502021-05-13
B5502668503PCRopsisConcentrator2668502021-05-13
B550ENT0010OpsisDxNuTec ChamberENT0012021-08-26
B550ENT0020OpsisDxSignal EnhancerENT0022021-08-26
B550ENT0040OpsisDxStandard MediaENT0042021-08-26
B550ENT0070OpsisDxTesting TrayENT0072021-08-26
B5502280010PCRopsisActivator2280012021-08-24
B5503580250PCRopsisElution Buffer3580252021-08-24
B5503581000PCRopsisElution Buffer3581002021-08-24
B55022760100PCRopsisBCS Nano22760102021-06-08
B55022761000PCRopsisBCS Nano22761002021-06-08
B550227610000PCRopsisBCS Nano227610002021-06-08
B550783780250PCRopsisReagent RVD-RT783780252021-05-12
B550783781000PCRopsisReagent RVD-RT783781002021-05-12
B5507837810000PCRopsisReagent RVD-RT7837810002021-05-12
B5502820250PCRopsisReagent Buccal2820252021-04-19
B5502821000PCRopsisReagent Buccal2821002021-04-19
B55028210000PCRopsisReagent Buccal28210002021-04-19

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Primary DI, Brand, Company table
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